medical device registration in japan
DESCRIPTION
Emergo Group presents an overview of the medical device registration process in Japan.TRANSCRIPT
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Japan’s regulatory process for medical devices
Medical Device Registration in Japan In this presentation… • Why Japan? • Characteristics of the Japanese market • Overview of the regulatory process • Device classification scheme • Foreign Manufacturer Accreditation • MHLW Ordinance #169 • In-country representative (D-MAH) • Registration certificate validity • Length of the process • How much it costs
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Japan’s regulatory process for medical devices
Why export to the Japanese market?
• Population of 127 million, 3rd largest global economy
• Japan’s medical device market totals $27 billion
• Expected to reach $39 billion by 2015
• Japan’s population is aging at a faster rate than any other developed nation, spurring more demand for healthcare
• Solid domestic device market, but also huge importer
Sources: Japan External Trade Organization, Japan Ministry of Health, Labor and Welfare
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Japan’s regulatory process for medical devices
Japan’s population is shrinking, but…
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Japan’s regulatory process for medical devices
Demand for medical devices will grow because the median age is rising quickly, and older people utilize healthcare much more intensively.
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Japan’s regulatory process for medical devices
Why Japan? Opportunity for exporters…
USD $1 Euro €1 GBP £1
Cost to Japanese buyer in
July 2008 ¥106 ¥167 ¥210
Cost to Japanese buyer in
October 2011 ¥77 ¥106 ¥121
Change -27% -37% -42%
American, Canadian and European exporters are far more competitive with Japanese domestic producers than they were even 3 years ago.
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Japan’s regulatory process for medical devices
Japanese market characteristics
• Large, mature economy and medical device market • Large target universe • Daimyo System • Complex, expensive distribution system • Relationship based sales • Socialized healthcare system • Heavy regulatory requirements
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Japan’s regulatory process for medical devices
The Japanese regulatory process
START
Now we will explain the process…
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Japan’s regulatory process for medical devices
Step 1: Determine Regulatory Pathway
Your regulatory pathway is determined by your device classification according to the Japan Pharmaceutical Affairs Law (PAL) and the availability of a Japanese Medical Device
Nomenclature (JMDN) code
Class I Class II Class II Class III Class IV
Increasing risk to patient or user
General Specified Controlled
Controlled Highly Controlled
Highly Controlled
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Japan’s regulatory process for medical devices
Determining JMDN Codes
• Japan Medical Device Nomenclature (JMDN)
• Broadly based on Global Medical Device Nomenclature (GMDN)
• Proper code selection is critical!
• Need experienced professional fluent in Japanese to make correct selection as numbering system can differ
コード
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Japan’s regulatory process for medical devices
JMDN Codes Information
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Japan’s regulatory process for medical devices
JMDN Codes Information (translated) JMDN: Passer, suture, single-use (Code: 37839002) CLASSIFICATION: Class II DEFINITION: A surgical instrument for passing sutures and suture needles through tissue. Typical passers may be flexible or rigid rods with handles that have hooks, catches or clasps to hold the material being passed through the tissue. Passers may also be ring handled instruments with extended, straight or slightly curved blades. The device is single use. CERTIFICATION STANDARD: No. 425: Certification Standard for Single use products to which JIS T0993-1 is applied. APPLICABLE JIS: JIS T0993-1 INTENDED USE: To be used for puncturing a hole through tissues to pass sutures or suture needles
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Japan’s regulatory process for medical devices
Application Review Categories
New No existing applicable JMDN code
Improved Existing JMDN Code with submission based on new technical file
Me-too Existing JMDN code with submission based on a registered technical file
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Japan’s regulatory process for medical devices
Application Modules
Class IV: New device
Class IV: Improved device (with clinical investigation)
Class II or III: New device
Class II or III: Improved device (with clinical investigation)
Class IV: Generic device (with approval standard, without CI)
Class II or III: Generic device (with approval standard , without clinical investigation)
Class IV: Improved device (without approval standard or clinical investigation)
Class IV: Generic device (without approval standard or clinical investigation)
Class II or III: Improved device and Generic device (without approval standard or clinical investigation)
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Japan’s regulatory process for medical devices
Step 2: Appoint Marketing Authorization Holder
Manufacturers with no local presence in Japan must appoint a Marketing Authorization Holder (MAH) or Designated MAH (D-MAH)* to manage their device registration process and liaise with the Pharmaceutical and Medical Devices Agency
(PMDA), Japan’s medical device market regulator.
* A D-MAH is required to register medical devices on behalf of foreign manufacturers
according to Japan’s Foreign Special Approval System.
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Japan’s regulatory process for medical devices
MAH and D-MAH Requirements • Must be based in Japan • Must be formally licensed by
the Ministry of Health, Labor and Welfare (MHLW)
• Must employ at least three staff members: general manager, quality manager and safety manager
• Must implement GQP and GVP systems
Far more legal, logistical and regulatory responsibility than European Authorized Representative or US FDA Agent!
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Japan’s regulatory process for medical devices
Step 3: Submit Foreign Manufacturer Accreditation Application
Submissions to the PMDA must include:
• Application for medical device Foreign Manufacturer Accreditation (Form No. 18)
• Supporting documentation such as medical certificates, product lists and facilities summaries
• Registration form to obtain a manufacturing code
Foreign Manufacturer Accreditation applications are submitted to the PMDA by your MAH.
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Japan’s regulatory process for medical devices
Step 4: Quality System Compliance
• Manufacturers of Class II, III and IV devices must implement a quality systems compliant with the Pharmaceutical Affairs Law and MHLW Ordinance #169 and submit QMS Conformity Assessment Application
• Similar to ISO 13485 and US Quality System Regulation (21 CFR Part 820)
Class II Specified Controlled
Class II Controlled
Class III Class IV
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Japan’s regulatory process for medical devices
Ordinance 169 basics…
•ISO 13485 is a certification process, whereas Ordinance 169 compliance is an accreditation for foreign manufacturers and a licensure for domestic manufacturers •Role of MAH – Defines the CUSTOMER as the MAH or other organization that is receiving products •Record and document retention requirements – Ordinance 169 requires specific record retention times for documents and records, whereas ISO 13485 does not prescribe specific time frames
Although based largely on ISO 13485:2003, MHLW Ordinance 169 does differ from ISO 13485 in some regards.
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Japan’s regulatory process for medical devices
Ordinance 169 basics, continued • Requires that the Engineering Manager is defined as the Management
Representative, whereas under ISO 13485 anyone can fill that role
• Infrastructure Requirements – requirements for facilities, environment, and infrastructure are more detailed in Ordinance 169 than in ISO 13485
• Defines special traceability and monitoring requirements for the classification of Specially Designated Medical Devices
• Requires documented procedures for adverse event reporting, advisory notices, and recalls to inform the MAH, which is not specifically required by ISO 13485
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Japan’s regulatory process for medical devices
Step 5: Submission to PMDA or RCB
Application submission requirements to the PMDA depend on how your device is classified in the Japanese system.
Prepare Pre-market Approval Application and Supporting documents as attachment including the documents in Summary Technical Document Format and Submit to
PMDA
Submit pre-market Certification
Application to Registered
Certification Body
Submit pre-market Submission to
PMDA
Class I Class II Class II Class III Class IV
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Japan’s regulatory process for medical devices
Class I: Pre-market Submissions
• For a Class I low-risk device, file a Pre-market Submission (Todokede) to the PMDA
• The PMDA does not further assess your Class I device
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Japan’s regulatory process for medical devices
Class II Specified Controlled: Pre-Market Certification
• For a Class II Specified Controlled device, have your MAH submit a Pre-market Certification (Ninsho) application to a Registered Certification Body (RCB)
• RCBs are independent firms authorized by the MHLW to certify Specified Controlled devices
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Japan’s regulatory process for medical devices
List of Licensed Japanese RCBs
BSI Japan K.K. SGS Japan
Cosmos Corporation TÜV Rheinland Japan Ltd.
Fuji Pharma Co. Ltd. TÜV SÜD Japan Ltd.
Japan Association for the Advancement of Medical Equipment (JAAME)
UL Japan Inc.
Japan Quality Assurance Organization (JQA)
DEKRA Certification Japan K.K.
Japan Electrical Safety & Environment Technology Laboratories (JET)
Japan Chemical Quality Assurance Ltd.
Nanotec Spindler Co. Ltd.
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Japan’s regulatory process for medical devices
Class II Controlled, Class III and Class IV: Pre-Market Approval
• For a Class II Controlled, Class III or Class IV higher-risk device, have your MAH file a Pre-market Approval application (Shonin) with the PMDA
• Prepare a registration dossier in Summary Technical Document (STED) format for submission along with your Pre-market Approval application
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Japan’s regulatory process for medical devices
Step 6: Quality System Auditing
Class II, III and IV medical devices are required to undergo quality system audits prior to final certification.
QMS Audit by PMDA* or Prefectural Regulatory Authority QMS Audit by RCB
*The PMDA conducts on-site audits for new medical devices,
Class IV devices and devices requiring clinical investigations.
Class II Specified Controlled
Class II Controlled Class III Class IV
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Japan’s regulatory process for medical devices
Current as of October 2011
Manufacturer Type Cost
Manufacturer of New devices ¥933,500 (plus travel costs)
Manufacturer of biological devices
¥844,400 (plus travel costs)
Manufacturer of sterilized devices
¥229,800 (plus travel costs)
Manufacturer of other devices ¥155,400 (plus travel costs)
Packaging Manufacturer ¥84,800 (plus travel costs)
Quality System Audit Costs for Foreign Manufacturing Sites
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Japan’s regulatory process for medical devices
Step 7: Final PMDA or RCB Certification
Self-declaration; No Certification
from PMDA
Pre-market Certification
issued by RCB
Pre-market Approval Certificate Issued by MHLW; Certificate does not expire
0
months
3-6 months
8-16 months
Class I Class II Class II Class III Class IV
Approvals do not expire but are subject to ongoing QMS requirements.
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Japan’s regulatory process for medical devices
Final PMDA Review & Certification Costs Application Module MHLW fee Review Conf. Assess.
Class IV: New (with CI) ¥100,000 ¥8,705,500 ¥664,500
Class IV: Improved (with CI) ¥100,000 ¥6,213,000 ¥664,500
Class IV: Improved (without CI or AS) ¥33,000 ¥2,355,400 ¥68,500
Class IV: Generic (without CI or AS) ¥33,000 ¥1,767,700 ¥68,500
Class IV: Generic (without CI, with AS) ¥33,000 ¥429,200 ¥68,500
Class III: New (with CI) ¥100,000 ¥6,7213,300 ¥664,500
Class III: Improved (with CI) ¥100,000 ¥3,721,200 ¥664,500
Class III: Improved (without CI or AS) ¥33,000 ¥1,409,900 ¥68,500
Class III: Generic (without CI or AS) ¥33,000 ¥1,409,900 ¥68,500
Class III: Generic (without CI, with AS) ¥33,000 ¥344,100 ¥68,500
Class II: New (with CI) ¥100,000 ¥6,213,000 ¥664,500
Class II: Improved (with CI) ¥100,000 ¥3,721,200 ¥664,500
Class II: Improved (without CI or AS) ¥33,000 ¥1,409,900 ¥68,500
Class II: Generic (without CI or AS) ¥33,000 ¥1,409,900 ¥68,500
Class II: Generic (without CI, with AS) ¥33,000 ¥344,100 ¥68,500
Current as of October 2011
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Japan’s regulatory process for medical devices
Regulatory Process Summary Designated Marketing Authorization Holder (D-MAH) (only one contract would cover all product families)
EMERGO GROUP: ¥150,000 or ¥100,000 per month plus 3% or 5% of the invoiced vale of shipments
Time to completion: 4 to 6 weeks to licensing
Foreign Manufacturer Accreditation (only one per facility can be applied to multiple product registration applications)
EMERGO GROUP: ¥170,000 per facility.
MoHLW: will charge fees of ¥148,100 per facility for application processing
Time to completion: 6 to 8 weeks to licensing (typical)
Quality Management System Compliance/Review (Class II, III and IV medical devices)
EMERGO GROUP: ¥420,000 per site (typical)
RCB: fees vary, or
PMDA: between ¥155,400 and ¥933,500
Time to complete: done in parallel with application review by RCB or PMDA
Application and Summary Technical Document Preparation
EMERGO GROUP: fees vary by product between ¥450,000 and ¥3,750,000
Time to completion: 2 to 4 months (typical)
Product Registration Application Review
MHLW: ¥33,300 or ¥100,000
RCB: fees vary, or
PMDA: between ¥112,600 and ¥9,370,000
Time to completion: 3 to 16 months (typical)
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Japan’s regulatory process for medical devices
Additional Resources
Emergo Group Consulting Services for Japan:
http://www.emergogroup.com/services/japan
Regulatory chart of Japan’s Registration Process:
http://www.emergogroup.com/literature
List of Japanese regulatory documents:
http://www.emergogroup.com/resources/regulations-japan
Thank you for your time!
EmergoGroup.com